FDA bans Red Dye No. 3 from foods and drugs

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration banned Red Dye No. 3 from food, beverages and drugs on Wednesday, Jan. 15.

The Center for Science in the Public Interest, which brought the petition to ban red No. 3 in 2022, lauded the decision, calling it a win for public health.

“All Americans deserve foods free from harmful food additives,” Thomas Galligan, CSPI’s principal scientist for additives and supplements, said in a CSPI story on its website. “Removing Red 3 and other unsafe, unnecessary food chemicals from our food supply is a critical step for protecting consumers. We hope to see FDA and Congress act soon to reform the broken federal regulatory systems that have allowed unsafe chemicals to enter and stay in our food supply for so long.”

CSPI reports more than 9,000 U.S. food products contain Red Dye No. 3, according to data from the U.S. Department of Agriculture.

Red Dye No. 3 is a synthetic food dye that gives certain foods and drinks a bright, cherry-red color. The dye is also known as FD&C Red No. 3, Red Dye 3, Red 3 or erythrosine. FD&C stands for Food, Drug and Cosmetic.

The FDA banned the dye because some studies have found that it caused cancer in male lab rats that were exposed to high doses, and a law called the Delaney Clause requires the FDA to ban any additives found to cause cancer in people or animals.

The dye has not been shown to cause cancer in humans.

“Studies in other animals or in humans did not show the same effect and there is no evidence showing FD&C Red No. 3 causes cancer in humans,” says an FDA news release about the ban.

Manufacturers have until Jan. 15, 2027, to remove the dye from foods and Jan. 18, 2028, to remove it from drugs.

The color was banned in cosmetics in the U.S. in 1990 and from foods in California in 2023 as part of a law that will be implemented in 2027. It’s also restricted in other countries, including Australia, New Zealand and the European Union.

State Rep. Wade Williams, R-Earlington, who filed House Bill 95 on Jan. 7 to prohibit Red Dye 3 in Kentucky, praised the FDA’s decision. 

“I am pleased to see the FDA’s recent decision to ban Red Dye 3 in food, beverages and ingested drugs. We had been waiting long enough for the FDA to make a decision on this matter, and we were prepared to act on the issue at the state level if necessary,” he said in a statement. “I’m glad that the FDA has recognized the potential dangers of Red Dye 3, and I am thankful that Kentuckians will no longer have to worry about ingesting it.”